Summary of the invention
Large in order to overcome existing cervical spondylosis chemotherapeutic agent toxic and side effects, the prior art that the treatment of cervical spondylopathy effect is difficult to continue is not enough, the invention provides a kind of Chinese medicine composition for the treatment of cervical spondylosis, this Chinese medicine composition good effect, side effect is little, and it is made by following raw material: Rhizoma Curcumae Longae 10-50 part, Rhizoma Et Radix Notopterygii 10-20 part, Radix Angelicae Sinensis 5-20 part, Rhizoma dioscoreae 5-15 part, Radix Rehmanniae 5-10 part, Herba Lycopodii 5-15 part, Radix Pseudostellariae 5-15 part, Radix Ginseng 1-10 part, Fructus Lycii 5-15 part, Radix Achyranthis Bidentatae 9-15 part, Rhizoma Coptidis 9-15 part, Radix Angelicae Dahuricae 5-15 part, Radix Ophiopogonis 1.5-9 part, Radix Paeoniae Alba 5.5-15 part, Olibanum 6-9 part, Radix Glycyrrhizae 10-15 part.
Rhizoma Curcumae Longae property is hot, bitter, warm, returns spleen, Liver Channel, has the removing blood stasis circulation of qi promoting, the effect of inducing menstruation to relieve menalgia.The clinical breast side of body that is usually used in twinges, amenorrhea, lump in the abdomen, rheumatism shoulder arm pain, the diseases such as tumbling and swelling.The modern pharmacology experiment confirm, curcumin or Rhizoma Curcumae Longae extract have significant antiinflammatory, function of gallbladder promoting, blood fat reducing and antioxidation.Rhizoma Et Radix Notopterygii is conventional Chinese medicine.Medicinal history is long, first appeared in Shennong's Herbal, lists under the Radix Angelicae Pubescentis item.Rhizoma Et Radix Notopterygii bitter in the mouth, suffering, warm in nature.Has loose exterior cold curing rheumatism, the effect in sharp joint.Commonly used enrich blood when being classified as, regulating menstruation, Traditional Chinese medicine used as analgesic, its sweet-bitter flavor, warm in nature, having enriches blood invigorates blood circulation, menstruction regulating and pain relieving, the effect of moisturizing laxation, cures mainly that all cards of blood deficiency, menoxenia, amenorrhea dysmenorrhea, lump in the abdomen knot are poly-, the diseases such as weight, ulcer sores behind the asthenia cold abdominalgia, numbness of the skin, dryness of the intestine dyschezia, bloody dysentery.Modern pharmacology studies show that it all has multiple pharmacological effect for blood system, cardiovascular system.Rhizoma dioscoreae refers to the Rhizoma Dioscoreaes that is produced from ground such as Anhui, modern Jiangsu, and the Rhizoma dioscoreae stem is with aubergine usually, cures mainly insufficiency of the spleen lack of appetite, incessant chronic diarrhea, and the spleen reinforcing nourishing the stomach is arranged, the lung benefiting that promotes the production of body fluid, the effect of the kidney invigorating arresting seminal emission.The Radix Rehmanniae also is Radix Rehmanniae, the Scrophulariaceae herbaceos perennial.Sweet-bitter flavor, cold nature, GUIXIN, liver, kidney channel.The Herba Lycopodii suffering is loose, bitter dry, temperature is logical, and energy Eradicates rheumatism enters the especially kind the meridian dredging of liver.Control anemofrigid-damp arthralgia, joint aches, joint stuffiness can be treated with compatibilities such as Rhizoma Et Radix Notopterygii, Radix Angelicae Pubescentis, Ramulus Cinnamomi, the Radix Paeoniae Albas diseases such as anemofrigid-damp arthralgia, limb softening wood; It also has the effect of reducing swelling and alleviating pain, and the circulation promoting vein relaxing medicines such as polygamy Lignum Sappan, Eupolyphaga Seu Steleophaga, Flos Carthami, Semen Persicae are used for traumatic injury, the treatment of pain caused by ecchymoma.Radix Pseudostellariae has another name called Radix Ginseng, virgin ginseng.Tuber for Caryophyllaceae herbaceos perennial pseudostellaria heterophylla.Invigorating qi and benefiting blood arranged, promote the production of body fluid, the effect of tonifying the spleen and stomach.Be suitable for children's's summer heat of a specified duration do not move back, the disease of the weaknesses such as diet is depressed, the deficiency of the lung, cough, cardiopalmus and children's after being ill weak unable, spontaneous perspiration, night sweat, mouthful equality disease.The medical value of Radix Ginseng is high, just thinks in the Shennong's Herbal, and Radix Ginseng has the effect of " tonifying five ZANG-organs, peace spirit, decide soul, spasmolytic are throbbed with fear, removed pathogen, happy Fructus Alpiniae Oxyphyllae makes eye bright ".Pharmacological research shows that Radix Ginseng all has the blood sugar lowering effect to Normal Canine and alloxan cervical spondylosis dog, has obvious hypoglycemic activity to alloxan cervical spondylosis Mus.Its effect still can keep for 1~2 week after Radix Ginseng total saponins can obviously suppress the hyperglycemia of alloxan cervical spondylosis Mus and drug withdrawal.Clinical research shows, Radix Ginseng treatment cervical spondylosis not only can be improved general symptom such as weak, thirsty, weak etc., and can blood sugar lowering and glucose in urine.Be applicable to light, medium-sized Patients with Cervical Spondylopathy, Chinese medical discrimination is suffered from a deficiency of the kidney, gas deficiency of YIN person better efficacy, and the deficiency of YIN scorching person should not take.(formal name used at school: Lycium chinense) be the multi-branched shrub plant of Solanaceae Lycium, high 0.5-1 rice can reach more than 2 meters during cultivation Fructus Lycii.Distribution is all arranged both at home and abroad.The Fructus Lycii whole body is precious, bright Li Shizhen (1518-1593 A.D.) Compendium of Material Medica record: " spring is adopted Folium Lycii, name day smart grass; Summer picks flowers, the name Sempervivum tectorum; Qiu Caizi, the name Fructus Lycii; Dong Caigen, the name Cortex Lycii ".The Fructus Lycii tender leaf also claims the Fructus Lycii head, edible or make Fructus Lycii tea.Modern study, Fructus Lycii have blood sugar lowering, lipotropy, and can antiatherogenic effect.Radix Achyranthis Bidentatae is the plant of Amaranthaceae Achyranthes, and its property bitter but sweet flavor acid is flat, has promoting blood circulation to restore menstrual flow, invigorating the liver and kidney, bone and muscle strengthening, inducing diuresis for treating stranguria syndrome draws the descending effect of blood (fire), be usually used in treating the gynaecopathia such as amenorrhea, dysmenorrhea, menoxenia, puerperal abdonimal pain of stagnation of blood stasis, traumatic injury, the soreness of waist and knee joint of suffering from a deficiency of the kidney, weakness of the lower extremities, hematuria; dysuria, Urethra astringent pain and intimately go up the cards such as headache that inflammation causes, dizzy, haematemesis, epistaxis.Rhizoma Coptidis has another name called Wang Lian, and bitter in the mouth is cold in nature, and is nontoxic.GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel.Has heat clearing and damp drying, the effect of eliminating fire and detoxication.The Radix Angelicae Dahuricae, warm in nature, acrid in the mouth is little sweet, has expelling wind and removing dampness; Logical surreptitiously pain relieving; The effect of detumescence and apocenosis.
[0018]Have another name called Radix Ophiopogonis Radix Ophiopogonis, is Liliaceae Ophiopogon plant.Be used as medicine with tuber Radix Ophiopogonis.Nature,taste and action: sweet, little hardship, cold, Yin-nourishing and body fluid promoting, nourishing the lung to arrest cough, relieving restlessness clears away heart-fire.Cure mainly consumption of body fluid caused by febrile disease, vexed, thirsty, dry pharynx lung-heat, cough, pulmonary tuberculosis.The Radix Paeoniae Alba is the famous traditional parts of generic medicinal plants of China, and applicating history is long, and Radix Paeoniae begins to be stated from Eastern Han Dynasty's Shennong's Herbal, classifies middle product as, and note has " main pathogen, Radix Paeoniae Alba stomachache is removed arthralgia due to stagnation of blood, and is broken hard long-pending, cold and heat hernia abdominal mass, pain relieving, diuresis, QI invigorating ".Olibanum, the bitter temperature of property enters the heart, liver, spleen channel.Regulating qi and activating blood, analgesic therapy chases after poison.Clinically control coagulation of QI-blood, trusted subordinate's pain, carbuncle pyogenic infections from tumour or sore, traumatic injury, dysmenorrhea, the diseases such as postnatal blood stasis twinge.
Chinese medicine composition of the present invention take except amassing numbness, dispersing wind and cold, wind-damp dispelling, bone and muscle strengthening as main standard, has significant antiinflammatory, analgesia and activating blood circulation to dissipate blood stasis effect after the Chinese medicine composition combination of the present invention on Chinese medicinal components is selected.The present invention has carried out preferably the parts by weight of above-mentioned all flavor Chinese medicine, and preferred condition is that drug matching uses rear medicine to the enhancing for the treatment of of cervical spondylopathy effect.As a preferred embodiment of the present invention, Chinese medicine composition of the present invention is made by the raw material of following weight portion: 30 parts in Rhizoma Curcumae Longae, 15 parts of Rhizoma Et Radix Notopterygiis, 15 parts of Radix Angelicae Sinensis, 10 parts of Rhizoma dioscoreaes, 8 parts in the Radix Rehmanniae, 10 parts of Herba Lycopodiis, 10 parts of Radix Pseudostellariaes, 6 parts of Radix Ginsengs, 10 parts of Fructus Lyciis, 12 parts of Radix Achyranthis Bidentataes, 12 parts of Rhizoma Coptidis, 10 parts of the Radixs Angelicae Dahuricae, 5.5 parts of Radix Ophiopogonis, 10 parts of the Radix Paeoniae Albas, 8 parts of Olibanums, 12 parts in Radix Glycyrrhizae.
Preferably, Chinese medicine composition of the present invention also further contains 7 parts of Rhizoma Chuanxiongs, 5 parts of Fructus Citris, 9 parts of Radix Polygalaes.The hot temperature of Rhizoma Chuanxiong is fragrant dry, walks and does not keep, can go loose, the up top, mountain peak that reaches; Enter again blood system, the descending sea of blood that reaches.Fructus Citri has another name called citron, is the Rutaceae citrus plant, and Fructus Citri acrid in the mouth, little hardship, acid are warm in nature; Return liver, lung, spleen channel; The fragrant row of gas is loose, can rise and can fall; Have depressed liver-energy dispersing and QI regulating, the chest stuffiness relieving reduces phlegm, dehumidifying and in effect, cure mainly distending pain in the chest and hypochondrium, cough with copious phlegm, gastral cavity abdomen painful abdominal mass pain, dyspepsia vomiting, edema beriberi.Radix Polygalae is conventional Chinese medicine, and is warm in nature, bitter in the mouth, suffering, and the function of have the Fructus Alpiniae Oxyphyllae of calming the nerves, eliminate the phlegm, subsiding a swelling is used for insomnia and dreamful sleep, forgetful palpitation with fear that disarmony between the heart and kidney causes, staring spells, expectoration is not well, sore swollen toxin, breast swell and pain.
In order to express better Chinese medicine composition of the present invention, Chinese medicine composition of the present invention can be prepared into dosage form commonly used clinically.Such as, the preparations such as powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, syrup, tablet, capsule.Preferably, Chinese medicine composition of the present invention is prepared into powder, water preparation, tablet or capsule according to conventional preparation technology.
The present invention also provides a kind of preparation method of Chinese medicine composition described above, it comprises the steps: to get the above-mentioned Chinese crude drug of recipe quantity and is broken into coarse powder, adding volumetric concentrations according to 4~9 times of the coarse powder gross weight is 40%~95% alcoholic solution, reflux, extract, three times, return time are 2~5h, filter, filtrate recycling ethanol, cold filtration washes with water, namely gets Chinese medical concrete after the drying; Those skilled in the art can be at the technical clinically conventional Chinese medicine pharmaceutical dosage form for preparing of this preparation method, such as tablet, capsule etc.
The present invention also asks for protection the purposes of above-mentioned Chinese medicine composition in preparation treatment cervical spondylosis medicine.Pharmaceutical composition of the present invention demonstrates significant anti-inflammatory and antalgic, activating blood circulation to dissipate blood stasis activity when the treatment cervical spondylosis.Drug effect embodiment of the present invention 19 shows, with model group relatively, during Chinese medicine composition of the present invention is low a Senior Three dosage group all can significantly reduce the dimethylbenzene induced mice the ear swelling value (
P<0.01), show that Chinese medicine composition of the present invention has the effect of the mice ear that remarkable inhibition dimethylbenzene induces, and there is significant dose-effect relationship in its reduction effect to ear swelling.Under the same experiment condition, positive control drug JINGTONGLING group also significantly reduce the ear swelling value (
P<0.05), but its antiphlogistic effects obviously not as good as Chinese medicine composition of the present invention.Drug effect embodiment 20 of the present invention shows, mice licks foot response latency time showing, compare with model group, after the administration behind 1h and the 2h, the mice of each administration group of Chinese medicine composition of the present invention is added the incubation period of foot reaction all greater than model group, have dose-dependence, and the incubation period of high dose group significantly greater than model group (
P<0.05).Illustrate that this Chinese medicine composition of the present invention can prolong mice to adding the sufficient response latency that hot plate stimulates, has certain analgesic activity.Under the same experiment condition, positive control drug JINGFUKANG KELI group (
P<0.05) and the JINGTONGLING group (1h,
P<0.05; 2h,
P<0.01) also significant prolongation mice incubation period of adding foot reaction, certain analgesic activity is arranged.Drug effect embodiment of the present invention 21 shows, model group and normal control comparison, whole blood hangs down cut index, erythrocyte aggregation index, Casson viscosity and plasma viscosity all to be had significantly and increase (
P<0.05).Compare with model group, basic, normal, high each dosage group of the Chinese medicine composition of the present invention all remarkable or utmost point has reduced the low cut index of whole blood, erythrocyte aggregation index, Casson viscosity and plasma viscosity significantly, reduction amplitude amount effect relationship, wherein high dose there were significant differences (
P<0.05).Under the same experiment condition, positive control drug JINGFUKANG KELI group and the spirit group that steps have also reduced the high cut index of whole blood, whole blood hangs down cut index, erythrocyte aggregation index, but it improves effect all not as good as Chinese medicine composition of the present invention to the hemorheology index.The result of liver index adds up demonstration, and model group and normal control compare, and the liver index significantly increases.And with model group relatively, basic, normal, high each dosage group of Chinese medicine composition of the present invention significantly reduced the liver index (
P<0.01), positive control drug JINGFUKANG KELI and Chinese medicine composition of the present invention Chinese medicine composition high dose group of the present invention can reduce significantly the liver index (
P<0.05), but effect not as good as Chinese medicine composition of the present invention.
In a word, pharmaceutical composition of the present invention compared with prior art has following advantage aspect the treatment cervical spondylosis:
1) compares with positive control drug JINGFUKANG KELI or JINGTONGLING; pharmaceutical composition Chinese medicine composition of the present invention is not only more remarkable at antiinflammatory and ease pain; and aspect activating blood circulation to dissipate blood stasis, also significantly be better than positive drug; this shows that the present composition has significant synergism in treatment of cervical spondylopathy; not only can significantly improve the symptom of cervical spondylosis; can also delay the development of cervical spondylosis, the generation of complication.
2) compare with the chemotherapeutic agent of current treatment cervical spondylosis, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and side effect significantly reduce, and Chinese medicine composition effect of the present invention is comprehensive, medication effect is better, significantly improve the compliance of Patients with Cervical Spondylopathy, and improved Quality of Life.
3) existing treatment of cervical spondylopathy medicine cervical spondylosis initial stage therapeutic effect still can, but along with obvious drug resistance problem all appears in the prolongation for the treatment of time, the therapeutic effect of cervical spondylosis descends.Contain the multi-medicament component in the Chinese medicine composition of the present invention, action target spot is numerous, has effectively solved the Commpensation And Adaptation for the treatment of of cervical spondylopathy medicine, and its therapeutic effect to cervical spondylosis does not descend because of the treatment time prolongation.
The specific embodiment
Below further describe the present invention by specific embodiment, the present invention is not limited only to following examples.
First's Chinese medicinal composition preparation of the present invention, preparation and using method thereof
Embodiment 1-6 Chinese medicine composition composition powders
Table 1 Chinese medicine composition composition powders prescription of the present invention
Embodiment 1 preparation method: get each medical material in the compositions, grind to form powdery according to common process, cross 100 mesh sieves, little fire drying is for subsequent use, namely gets powder.During use, with directly taking after mixing it with water behind the water dissolution.Embodiment 2-6 preparation method is with embodiment 1.
Embodiment 7-12 Chinese medicine composition water preparation
Table 2 Chinese medicine composition water preparation prescription of the present invention
Embodiment 7 preparation methoies: get each medical material in the prescription, according to conventional decocting for Chinese herbal medicine technological operation, filtering medicinal residues and get final product.This water preparation (or claiming decoction) when being used for treatment of cervical spondylopathy, take 2-3 time by every day.Embodiment 8-12 preparation method and using method are with embodiment 7.
Embodiment 13-18 Chinese medicine composition tablet/capsule of the present invention
Table 3 Chinese medicine composition tablet of the present invention/capsule prescription
Embodiment 13 preparation technologies: each traditional Chinese medicine powder of getting recipe quantity is broken into coarse powder, and adding volumetric concentrations according to 5 times of the coarse powder gross weight is 80% alcoholic solution, reflux, extract, three times, the each 3h of return time filters filtrate recycling ethanol, cold filtration washes with water, namely gets Chinese medical concrete after the drying; Dried cream powder is made in Chinese medical concrete drying, pulverizing, added conventional adjunct ingredient and utilize prior art to be prepared into tablet or capsule.
Embodiment 14-18 preparation technology is with embodiment 13.
Second portion Chinese medicine composition pharmacodynamic study of the present invention
Embodiment 19 Chinese medicine composition xylol of the present invention cause the impact of mice ear
Get 72 of healthy ICR mices, ♀ ♂ half and half, divide 6 groups, 12/group, be model group, JINGFUKANG KELI (Chengde JingFuKang pharmacy Group Co.,Ltd, lower same), JINGTONGLING group (Yantai Zhichu Pharmaceutical Co., Ltd.), Chinese medicine composition of the present invention (making by embodiment 1 described Chinese medicine composition prescription and preparation technology) low dose group, middle dosage group and high dose group.1 time/d of every ig administration; Administration 14 d, 60 min behind the last medicine, mouse right ear evenly smear dimethylbenzene 0.03 mL/ and only cause swollenly, cut ears behind the 2h and beat auricle and weigh, and calculate ear swelling value (mg).Swelling value=auris dextra weight-left ear weight.
The result shows, with model group relatively, during Chinese medicine composition of the present invention is low a Senior Three dosage group all can significantly reduce the dimethylbenzene induced mice the ear swelling value (
P<0.01), show that Chinese medicine composition of the present invention has the effect of the mice ear that remarkable inhibition dimethylbenzene induces, and there is significant dose-effect relationship in its reduction effect to ear swelling.Under the same experiment condition, positive control drug JINGTONGLING group also significantly reduce the ear swelling value (
P<0.05), but its antiphlogistic effects obviously not as good as Chinese medicine composition of the present invention.
The impact of table 4 Chinese medicine composition xylol of the present invention induced mice ear swelling (
)
Annotate: compare * with model group
P<0.05, * *
P<0.01
Embodiment 20 Chinese medicine compositions of the present invention are on the impact of mice hot-plate analgesia
20.1 mice hot plate pain model is made
Body weight 20g left and right sides female mice is placed on the hot plate dolorimeter, screen 90 of qualified ♀ mices (lick metapedes time<5 s or 30 s throw aside, scald for preventing foot, also should establish deadline, be generally 60s), add the incubation period of metapedes reaction as threshold of pain index take mice, get 72 jennies, be divided into 6 groups, 12/group, i.e. model group, JINGFUKANG KELI, JINGTONGLING group, Chinese medicine composition of the present invention (making by embodiment 1 described Chinese medicine composition prescription and preparation technology) low dose group, middle dosage group and high dose group.Each group is gastric infusion, and 1 times/day, dosage is as shown in table 10, behind the successive administration 14d, and the time that 60 min, 120 min add the foot reaction behind the mensuration last medicine.
Chinese medicine composition of the present invention is on licking the impact of foot response latency in the experiment of mice hot-plate analgesia
Mice licks foot response latency time showing, compare with model group, behind 1h and the 2h, the mice of each administration group of Chinese medicine composition of the present invention is added the incubation period of foot reaction all greater than model group after the administration, have dose-dependence, and the incubation period of high dose group significantly greater than model group (
P<0.05).Illustrate that this Chinese medicine composition of the present invention can prolong mice to adding the sufficient response latency that hot plate stimulates, has certain analgesic activity.Under the same experiment condition, positive control drug JINGFUKANG KELI group (
P<0.05) and the JINGTONGLING group (1h,
P<0.05; 2h,
P<0.01) also significant prolongation mice incubation period of adding foot reaction, certain analgesic activity is arranged.The results are shown in Table 5.
Table 5 mice lick the foot response latency timetable (
)
Annotate: compare * with model group
P<0.05, * *
P<0.01
Embodiment 21 Chinese medicine compositions of the present invention are to the improvement effect of rat blood stasis models
Get the healthy SD rat, body weight 180-200g, 70, male and female half and half, be divided at random 7 groups by body weight: basic, normal, high group of Normal group, model group, JINGFUKANG KELI group, JINGTONGLING group and Chinese medicine composition of the present invention (making by embodiment 1 described Chinese medicine composition prescription and preparation technology), 10 every group.Gastric infusion, successive administration 14 days, Normal group and model group are to 0.5%CMC, and all the other give corresponding medicine, and dosage is as shown in table 14.Administration the 13rd day, 14 days, except Normal group, all the other treated animals are pressed 1mg/Kg subcutaneous injection adrenalin hydrochloride, and 2 times/days, interval 4h, 2h puts animal in 4 ℃ of frozen water 15min after the injection for the first time.Administration was got 4-5ml blood anticoagulant heparin on the 15th day and is measured blood rheology parameter, got the liver conversion organ coefficient of weighing.
The result shows, model group and normal control comparison, whole blood hangs down cut index, erythrocyte aggregation index, Casson viscosity and plasma viscosity all to be had significantly and increase (
P<0.05).Compare with model group, basic, normal, high each dosage group of the Chinese medicine composition of the present invention all remarkable or utmost point has reduced the low cut index of whole blood, erythrocyte aggregation index, Casson viscosity and plasma viscosity significantly, reduction amplitude amount effect relationship, wherein high dose there were significant differences (
P<0.05).Under the same experiment condition, positive control drug JINGFUKANG KELI group and the spirit group that steps have also reduced the high cut index of whole blood, whole blood hangs down cut index, erythrocyte aggregation index, but it improves effect all not as good as Chinese medicine composition of the present invention to the hemorheology index.The result of liver index adds up demonstration, and model group and normal control compare, and the liver index significantly increases.And with model group relatively, basic, normal, high each dosage group of Chinese medicine composition of the present invention significantly reduced the liver index (
P<0.01), positive control drug JINGFUKANG KELI and Chinese medicine composition of the present invention Chinese medicine composition high dose group of the present invention can reduce significantly the liver index (
P<0.05), but effect not as good as Chinese medicine composition of the present invention.
The impact that table 6 becomes the rat blood stasis models blood flow (
)
Annotate: compare # with normal control
P<0.05, ##
P<0.01; Compare * with model group
P<0.05, * *
P<0.01
Table 7 on the impact of rat blood stasis models liver coefficient (
)
Annotate: compare ## with normal control
P<0.01; Compare * with model group
P<0.05, * *
P<0.01.